Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000270819
Ethics application status
Approved
Date submitted
2/12/2020
Date registered
11/03/2021
Date last updated
21/02/2022
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing coronary microcirculatory resistance by magnetic resonance imaging to invasive measurement of microcirculatory resistance
Scientific title
Magnetic resonance Imaging-based Coronary Resistance index cOmpared to the invasive index of microcirculatory resistance in patients with non-obstructive coronary artery disease
Secondary ID [1] 302433 0
None
Universal Trial Number (UTN)
U1111-1258-8896
Trial acronym
MICRO
Linked study record
This study is a sub-study of The Macro- and Micro-circulation in Coronary Heart Disease (ACTRN12619000450112)

Health condition
Health condition(s) or problem(s) studied:
Angina
 319243 0
Coronary microvascular disease 319244 0
Ischaemia and no obstructive coronary artery disease 319245 0
Condition category
Condition code
Cardiovascular 317216 317216 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with non-obstructive coronary artery disease on invasive coronary angiography will undergo a cardiovascular MRI scan 2 weeks after angiography to measure coronary microvascular resistance. The comprehensive MRI scan will take approximately 2 hours. There is no follow-up for this study.
Intervention code [1] 318718 0
Not applicable
Comparator / control treatment
Matched control participants have non-obstructive coronary artery disease with no evidence of microvascular resistance
Control group
Active

Outcomes
Primary outcome [1] 325282 0
The standardised distance (Z score) for the coronary resistance index by magnetic resonance imaging (MRI) between healthy volunteers and patients with increased index of microcirculatory resistance (IMR), compared to the Z score for IMR between the same groups, using the paired t-test or non-parametric test as appropriate.
Timepoint [1] 325282 0
Within 2 weeks after invasive coronary physiology assessment
Secondary outcome [1] 387391 0
CRI assessed by MRI
Timepoint [1] 387391 0
Within 2 weeks of enrolment

Eligibility
Key inclusion criteria
Patients with non-obstructive coronary artery disease who have had comprehensive invasive coronary physiology assessment with no evidence of microvascular disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obstructive coronary artery disease
Haemodynamic instability from cardiogenic shock
Severe asthma
Heavily calcified or tortuous vessels
Inability to provide informed consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Paired t-test or non-parametric test as appropriate for standardised distance (Z score).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/03/2022
Actual
Date of last participant enrolment
Anticipated
17/03/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17704 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 31559 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 306856 0
University
Name [1] 306856 0
University of Sydney
Country [1] 306856 0
Australia
Primary sponsor type
Individual
Name
Professor Martin Ugander
Address
Kolling Institute, Level 12, Royal North Shore Hospital, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 307414 0
None
Name [1] 307414 0
Address [1] 307414 0
Country [1] 307414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307015 0
Royal Prince Alfred Hospital
Ethics committee address [1] 307015 0
50 Missenden Road, Camperdown NSW 2050
Ethics committee country [1] 307015 0
Australia
Date submitted for ethics approval [1] 307015 0
Approval date [1] 307015 0
23/10/2020
Ethics approval number [1] 307015 0

Summary
Brief summary
Patients with non-obstructive coronary artery disease, who have had a comprehensive invasive coronary physiology assessment, will be asked to undergo a research cardiac MRI within two weeks of their invasive assessment. The results of the MRI will be compared to the invasive assessment. This will provide information on the utility of the new MRI method for diagnosis of coronary microvascular dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105742 0
Prof Martin Ugander
Address 105742 0
Kolling Institute, Level 12, Royal North Shore Hospital, St Leonards, NSW 2065.
Country 105742 0
Australia
Phone 105742 0
+612 9926 4760
Fax 105742 0
Email 105742 0
martin.ugander@sydney.edu.au
Contact person for public queries
Name 105743 0
Prof Martin Ugander
Address 105743 0
Kolling Institute, Level 12, Royal North Shore Hospital, St Leonards, NSW 2065.
Country 105743 0
Australia
Phone 105743 0
+612 9926 4760
Fax 105743 0
Email 105743 0
martin.ugander@sydney.edu.au
Contact person for scientific queries
Name 105744 0
Prof Martin Ugander
Address 105744 0
Kolling Institute, Level 12, Royal North Shore Hospital, St Leonards, NSW 2065.
Country 105744 0
Australia
Phone 105744 0
+612 9926 4760
Fax 105744 0
Email 105744 0
martin.ugander@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.